CQV Engineers Needed - Spring House, PA_Onsite job

Overview

On Site
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 6+ MO

Skills

Recruiting
Spring Framework
FOCUS
IQ
OQ
PQ
URS
Risk Assessment
Reporting
Auditing
Mapping
GAMP
Documentation
GDP
Storage
Laboratory Equipment
HVAC
Distribution
Electrical Engineering
Lighting
Power Supply
Adobe AIR
GMP
EMS
Element Management System
Management
Sensors

Job Details

Hiring for -

TITLE - CQV Engineers - Spring House, PA_Onsite job

They are going to need 25-30 CQV Engineers to assist on this project. Initial 6 12-month project.

The areas of focus will be on Cell Therapy and Temperature mapping



Need - LINEKDIN match with updated resume, no FAKE people

Multiple CQV Engineers needed to support a project in Spring House, PA. The scope includes thermal mapping and qualification of various GMP equipment, with a strong focus on controlled temperature units and laboratory devices.

You will be responsible for:

  • Preparation and execution of Qualification Protocols and Reports
    • Design Qualification (DQ)
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)
  • Review and/or authoring of supporting validation documentation
    • User Requirements Specifications (URS)
    • Risk Assessments (e.g., SIA)
    • Commissioning Test Report
  • Thermal mapping strategy definition and execution
  • Execution of FAT/SAT, where applicable
  • PCOM/CTP support and walkdown activities
  • Support during regulatory inspections and internal audits


About you:

  • Solid knowledge and proven experience with:
    • Equipment qualification in GMP-regulated environments
    • Temperature mapping and calibration
    • Understanding of GAMP5 principles
    • Good documentation practices (GDP)
  • Capability to handle multiple systems in parallel, following a risk-based approach to prioritize tasks
  • Experience in authoring and reviewing validation protocols and reports, including deviation management

Equipment in Scope:

  • Controlled Temperature Units & Storage:
    • Cryogenic Freezers
    • Ultra-low Freezers (-80 C)
    • Standard Freezers (-20 C)
    • Refrigerators
    • CO2 Incubators
    • General Incubators
    • Ovens
    • Stability Chambers
  • Safety & Laboratory Equipment:
    • Biosafety Cabinets
    • Fume Hoods
    • Flammable Cabinets
    • Lyophilizers
    • Cryostats
  • HVAC and Air Handling:
    • AHUs (Air Handling Units)
    • Room HVAC systems (supply/exhaust units)
    • HVAC Controls and Sensors
    • Client-connected ventilation devices
  • Clean Utilities:
    • Purified Water (PW) Distribution System
    • Clean Steam Supply
    • Clean Compressed Air
    • Nitrogen Lines for Clean Applications
    • WFI (if confirmed in detailed docs)
  • Black Utilities:
    • Electrical Panels and Subpanels
    • General Lighting and Emergency Power
    • Power Supply to Equipment
    • Grounding Systems
    • Compressed Air for Technical Use
    • Cooling/Heating loops (non-GMP)
  • Monitoring and Control Systems:
    • Environmental Monitoring System (EMS)
    • Building Management System (Client)
    • Temperature and Humidity Sensors
    • Alarming and Notification Panels

Thanks & Regards

Arun Kumar

Sr. Recruiter

Email:

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